Systemic Symptoms: Biospecimen Analysis Study

NCT04255810 | Completed

• 1 other identifier: ASERF-BII Study
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

An increasing number of women are reporting a collection of non-specific systemic symptoms thought to be caused by their breast implants. There is no current pathophysiologic explanation or diagnostic test for BII; it is not a recognized medical disease at this time. This study aims to address the questions asked by patients, physicians, and the FDA with regard to the scientific validity of BII.

Conditions

Women With Breast Implants With and Without Self-reported Systemic Symptoms; Women Undergoing an Elective Mastopexy (Breast Lift) or Small Reduction

Outcome Measures

Primary Outcomes (1)

• Change in self-reported systemic symptoms

  Change in self-reported symptoms on PROMIS (NIH) questionnaires

  3-6 weeks and 6 months and 1 year

Study Arms (3)

Women with breast implants and self-reported symptoms of BII

Women undergoing elective breast implant removal without replacement who self-report systemic symptons associated with BII

Procedure: Surgical collection of biospecimens

Women with breast implants and no self-reported BII

Women undergoing elective breast implant exchange or removal without self-reported symptoms of BII

Procedure: Surgical collection of biospecimens

Women undergoing elective mastopexy (breast lift)

Women undergoing an elective mastopexy (breast lift) without breast implants or soft tissue support

Interventions

Surgical collection of biospecimens PROCEDURE

Systemic blood and implant capsule tissue will be collected from two cohorts with breast implants, systemic blood only will be collected from Mastopexy cohort

Women with breast implants and no self-reported BII; Women with breast implants and self-reported symptoms of BII

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Genetic females between the ages of 30 and 65 who fall into one of the three cohorts.

You may qualify if:

• Consecutive patients who present to investigator surgeon for:
• Self-reported BII requesting explantation;
• Patient who presents for breast implant exchange or explantation without self-reported symptoms of BII;
• Patient who presents for a mastopexy or small reduction less than 200grams (without implants or soft tissue support);
• Willingness to follow study requirements including 3-6 week and 6 month follow-up exams; and
• Genetic Female.

You may not qualify if:

• Subject lives more than three hours away from the investigator surgeon;
• Previous breast reconstruction for cancer;
• Active malignancy anywhere else in the body;
• Has been implanted with any silicone implant other than a breast implant anywhere else in the body;
• History of radiation to the breast;
• Currently on anti-estrogen therapy; or
• HIV positive.

Sponsors & Collaborators

• Glicksman, Caroline, M.D.: lead
• The Aesthetic Surgery Education & Research Foundation: collaborator

Study Sites (1)

Glicksman Plastic Surgery

Sea Girt, New Jersey, 08750, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Systemic blood, breast implant capsule tissue

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigators

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 5, 2020
• Study Start: November 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

US (1)